Import Alert 34-02

"Detention Without Physical Examination of Confectionery Products Containing Non-Nutritive Components"

NOTE: Revision to this Import Alert dated 3/1/2012 updates the import alert format/language, modifies the reason for alert and guidance sections, and provides more specific product coding. Changes are noted and bracketed by three asterisks (***).

*** Import Alert 34-02 was created as the Agency was made aware of a product called "Kinder Surprise Eggs", and similar articles containing imbedded, non-nutritive objects, being offered for sale in the United States. The imbedded non-nutritive objects in these confectionary products may pose a public health risk as the consumer may unknowingly choke on the object. ***

Section 402(d)(1) of the Federal Food, Drug, and Cosmetic Act provides that confectionery having partially, or completely imbedded therein, any non-nutritive object is adulterated unless FDA has issued a regulation recognizing that the non-nutritive object is of practical functional value to the confectionery product and would not render the product injurious or hazardous to health.

*** This import alert has been developed for specific manufacturers and shippers that have offered adulterated, confectionary products containing non-nutritive objects for entry and have met the criteria for detention without physical examination as established in FDA¿s Regulatory Procedures Manual (RPM). ***

*** Districts may detain, without physical examination, the indicated products from the firms identified on the Red List of this Alert. ***

Districts should also notify the following federal government agencies of FDAs findings of a non-nutritive object imbedded in a confectionary product:
Consumer Product Safety Commission (CPSC), Office of Compliance and Field Operations (301-504-7520). CPSC will address any choking hazard associated with the non-nutritive object, e.g., a toy, under their regulations. FDA and CPSC have cooperated in this manner regarding Kinder Surprise type products in the past; and,
Local U.S. Customs and Border Protection (CBP).

*** Refer to Compliance Policy Guides (CPG) Sec. 515.100 & 515.350 for guidance related to non-nutritive substances in confectionary products.

In order to remove a firm from detention without physical examination, information should be provided to FDA to adequately demonstrate that the manufacturer has resolved the conditions that gave rise to the appearance of the violation, so that the agency will have confidence that future entries will be in compliance.

For guidance on removal from detention without physical examination, refer to FDAs Regulatory Procedures Manual, Chapter 9, "Detention Without Physical Examination (DWPE)."

If a firm, shipper or importer wishes to request removal from detention without physical examination, they should forward information supporting their request to FDA at the following address:

Food and Drug Administration
Division of Import Operations and Policy (HFC-170)
12420 Parklawn Drive, ELEM-3109
Rockville, MD 20857

Or be sent via email: Importalerts2@fda.hhs.gov

For questions or issues involving import operations, contact the Division of Import Operations & Policy at (301) 796-0356.

For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Division of Field Science at 301-796-6600.

For questions on policy or sample collection recommendations contact the Office of Compliance, Division of Enforcement, CFSAN, at (240) 402-1750. ***

Confectionery products containing non-nutritive components, such as small toys or objects, which may be partially or completely imbedded in the food product.

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a confectionery that has a partially or completely imbedded non-nutritive object [Adulteration, Section 402(d)(1)].

OASIS Charge Code - IMBED OBJT